Regulation of Chocolate by the U.S. Food & Drug Administration

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            Regulation of Chocolate by the
            U.S. Food & Drug Administration

            Torrey Cope
            March 2013

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Sidley’s African & Asian Trade,
    Investments & Finance (TIF) Program

• Provides pro bono legal assistance to farm and fishery
  associations/cooperatives, small agribusiness
  processors, and input providers in Africa & Asia

• Focused on enhancing trade and development by
  enabling clients to access market opportunities

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Who is FDA?

• Federal administrative agency within the Department of
  Health & Human Services
• Responsible for protecting the public health by assuring the
  safety, efficacy, and security of:
    – Human and veterinary drugs
    – Biological products
    – Medical devices
    – Foods intended for humans and animals
    – Cosmetics
    – Products that emit radiation
    – Tobacco products
• Issues and enforces legally binding requirements

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Adulteration and Misbranding

• Food Adulteration
    – Contains poisonous or deleterious substances which
      may render food injurious to health
    – Manufactured in unsanitary conditions
    – Economic adulteration
• Food Misbranding
    – A food is misbranded if, among other things, its labeling
      is false or misleading in any particular
    – Both affirmative statements and omissions of fact can
      be challenged as misleading (e.g., food allergen
      information)

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                     See 21 U.S.C. §§ 342-343

Regulation of Food Safety

• Facility registration and recordkeeping
• Good Manufacturing Practice (GMP) /
  Hazard Analysis & Critical Control Points (HACCP)
• Inspections
• Import controls
• Reportable food registry
• Recalls
• Food Safety Modernization Act (FSMA)
    – Increased inspection of foreign food facilities
    – New importer programs

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Standards of Identity for Foods

• FDA may issue standard of identity for any food in order to
  “promote honesty and fair dealing in the interest of
  consumers”
   – Typically defines the essential and optional ingredients to
     be used
   – May also define minimum levels for valuable ingredients,
     maximum values for fillers, and/or the manufacturing
     process to be used
• Often initiated by industry petition
• Codified in FDA regulations
• Examples:
   – Cheese
   – Chocolate

                       See 21 U.S.C. § 341;
                      21 C.F.R. Parts 130-169

Chocolate Standards

• Include a definition of “chocolate,” which is a food
  prepared by finely grinding cacao nibs
• Include definitions for other products that contain
  “chocolate”:
   – Sweet chocolate
   – Milk chocolate
   – Buttermilk chocolate
   – Skim milk chocolate
   – Mixed dairy product chocolates
• Also include a definition for “white chocolate”

                      See 21 C.F.R. Part 163

Chocolate Standards

• Products covered by the standards generally must
  contain “chocolate” and may also include:
   – Cacao fat
   – Nutritive carbohydrate sweeteners
   – Certain spices, flavorings, and seasonings
   – Dairy ingredients

Labeling Requirements

• All foods must bear an identity statement that
  consists of one of the following
     – Common or usual name
     – Appropriately descriptive term or “fanciful name”
     – Statement required by an applicable law or rule
• For a food subject to a standard of identity:
     – Must bear name of the food specified in the standard, if
       it conforms to the standard
     – Prohibited from bearing the name, if it does not conform
       to the standard

                       See 21 U.S.C. § 343(g);
10                       21 C.F.R. § 101.3

Options for Marketing a Food Subject to a
           Standard of Identity
• Comply with the standard, and use the name of the
  food specified in the standard
• Use a name that is not a standardized term
   – E.g., “chocolate flavored candy”
• Amend the standard of identity
• Obtain a temporary marketing permit

Consequences of Non-compliance

• Establishment inspections
• Seizures
• Injunctions, including restitution, disgorgement and liquidated
  damages
• Recalls, including voluntary and mandatory (in certain cases)
• Civil monetary penalties
• Informal compliance correspondence, including warning letters
  and untitled letters
• Publicity
• Import inspections
• Product approval or license withdrawals and suspensions and
  “alert/reference” lists
• Debarment
• Criminal liability, including personal criminal liability

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Questions?

• Contact:
•    Torrey Cope
•    (202) 736-8803
•    tcope@sidley.com

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Backup Slides

Current Focus on Food Safety

Current Focus on Food Safety

• GAO considers food safety a “high risk” area:
   – Substantial and increasing portion of food supply is
     imported
   – Consumers eating more raw and minimally processed
     foods
   – Growing segments of population susceptible to
     foodborne illness

 “[FDA] cannot wait until
 the food arrives at our
 borders…extending the
 FDA’s global reach is key to
 our success.”
 – Dr. Margaret Hamburg, FDA Commissioner (April
 2010 Food and Drug Law Institute Annual Conference)

Food Safety Modernization Act (FSMA)

• Signed into law on January 4, 2011
• Key import-related provisions:
     – Increases inspection of foreign food facilities
     – Requires certification for high-risk food imports
     – Adds importer programs
        • Foreign Supplier Verification Program (FSVP)
        • Voluntary Qualified Importer Program (VQIP)
     – New third-party auditor accreditation
     – Greater foreign capacity building/FDA Foreign Offices

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